Cluster-randomized controlled trial of gastric cancer prevention by community eradication of Helicobacter pylori

Affecting more than 40% of the world’s population, Helicobacter pylori is a major risk factor for gastric cancer. While previous clinical trials indicated that eradication of H. pylori could reduce gastric cancer risk, this remains to be shown using a population-based approach. In a community-based, cluster-randomized, controlled, superiority intervention in 980 villages in Linqu County, China, individuals who tested positive for H. pylori using a ¹³C-urea breath test were randomly assigned to receiving either (1) a 10-day, quadruple anti-H. pylori treatment (omeprazole, tetracycline, metronidazole, and bismuth citrate) or (2) symptom alleviation (omeprazole and bismuth citrate). H. pylori-negative individuals did not receive any treatment. The incidence of gastric cancer was the primary outcome. A total of 180,284 eligible participants were enrolled over 11.8 years of follow-up, and a total of 1,035 cases of incident gastric cancer were documented. Individuals receiving anti-H. pylori treatment showed a modest reduction in gastric cancer incidence in intention-to-treat analysis (HR 0.86; 95% CI 0,74-0,99), with a stronger effect observed for those having successful H pylori eradication (0.81; 0.69-0.96) than for those who failed treatment. Moderate adverse events were reported in 1,345 participants during the 10-day treatment, while there were no severe adverse events during treatment or follow-up. The authors conclude that these findings suggest the potential for H.pylori mass screening and eradication as a public health policy for gastric cancer prevention.